Galpharm Mild Diarrhoea Relief Tablets
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Entrocalm
Diarrhoea relief tablets Asda Upset Stomach Tablets Galpharm Mild Diarrhoea Relief Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Light kaolin BP 400 mg Calcium carbonate BP 75 mg
3. PHARMACEUTICAL FORM
Tablets
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
For the treatment of mild diarrhoea and holiday tummy.
4.2. Posology and Method of Administration
For oral administration.
Adults and children over 12 years: Five tablets to be chewed for times a day if necessary.
Children 6 to 12 years of age: Two tablets to be chewed four times a day if necessary.
4.3.
Contra-Indications
None known.
4.4. Special Warnings and Special Precautions for Use
None other than the following which will appear on the labelling.
If diarrhoea has not cleared up within three days consult your doctor.
Do not exceed the stated dose.
Keep out of the sight and reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
Changes in gastric acidity, such as that caused by the ingestion of antacids, can affect the rate and degree to which some concurrently administered medicines are absorbed. Due to the presence of calcium carbonate which acts as an antacid, a time-interval of 2 hours should be considered between [PRODUCT] intake and the administration of other medicinal products.
The absorbent properties of kaolin may influence the gastro-intestinal absorption of other drugs. e.g. lincomycin digoxin. The calcium carbonate/kaolin mixture may also reduce the absorption of the following: cimetidine, chlorpromazine, diflunisal, pivampicillin, tetracycline and ketaconazole.
4.6. Pregnancy and Lactation
The tablets may be used in the above conditions.
4.7. Effects on Ability to Drive and Use Machines
None.
4.8 Undesirable Effects
None known.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
May cause hypercalcaemia and alkalosis.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
Light kaolin is absorbent when given by mouth, it absorbs toxic and other substances from the alimentary tract and increases the bulk of the faeces.
Calcium carbonate is an antacid with constipatory effects.
5.2 Pharmacokinetic Properties
None stated,
5.3 Pre-clinical Safety Data
There are no pre - clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Icing Sugar, Maize Starch BP, Talc BP, Clove Oil BP, Cinnamon Oil BP, Nutmeg Oil BP, Magnesium Stearate BP and Erythrosine (E127).
6.2 Incompatibilities
None.
6.3
Shelf-Life
3 years in blister packs.
5 years in amber glass bottles.
6.4 Special Precautions for Storage
Store below 250C in a dry place.
6.5 Nature and Content of Container
Blister packs comprised of 20pm aluminium foil and 250pm PVC enclosed in an outer carton containing 24,36,48, or 60 tablets.
Amber glass bottles with plastic screw caps containing 50 tablets.
6.6 Instructions for Use/Handling
Not applicable.
7. MARKETING AUTHORISATION HOLDER
Galpharm Healthcare Limited
Wrafton
Braunton
Devon
EX33 2DL
United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
PL 16028/0008
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE
AUTHORISATION
22 September 1997
10 DATE OF REVISION OF THE TEXT
26/09/2014